Effect of Transcutaneous Electrical Nerve Stimulation in Peripheral Artery Disease TENS-PAD Study / TENS-AOMI

Peripheral Artery Disease Clinical Trial

— TENS-PAD  

Official title:

Efficacy of Transcutaneous Electrical Nerve Stimulation in the Improvement of Walking Distance in Patients With Peripheral Artery Disease With Intermittent Claudication

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02678403
• Other study ID #: RC31/14/7386
• Secondary ID: 2015-A01534-45
• Status: Terminated
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: September 16, 2019

Study information

• Verified date: January 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose: The investigators team recently carried out a proof of concept study testing the efficacy of one single 45-minute session of 10 Hz TENS prior to walking, versus placebo. In this randomized study, the investigators found that TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class II PAD. From these encouraging results, the investigators now seek to assess the efficacy of an intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in PAD (Leriche-Fontaine stage II). Methods/Design: prospective multicentre study / randomized controlled trial / double blinding.

Description:

Interventions (2 groups): Experimental group (TENS group): the treatment will consist of stimulation of the leg (frequency of 10 Hz, Biphasic, with a pulse width of 200 µs, maximal intensity below motor threshold), 45 minutes per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. Control group (group SHAM): the stimulation placebo will be delivered according to the same modalities as for the TENS group but with a voltage level that vanishes automatically after 10 seconds of stimulation.

15 days of interventions (TENS or SHAM) between J0 and J23, End of study for patient at J24-J25, two days for the last analyses who are the same of inclusion's visit J0.

Primary outcome: walking distance (metres) measured on a treadmill with a standardized protocol. Secondary outcomes: transcutaneous oxygen pressure (TcPO2) measured during a Strandness exercise test, peak oxygen uptake (VO2 peak) (ml.min.kg-1), endothelial function (EndoPAT®), ankle-brachial pressure index, body mass index, lipid profile (LDL-C, HDL-C, Triglycerides), fasting glycaemia, HbA1c, WELCH questionnaire.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Unilateral Leriche stage II PAD, admitted to cardiovascular Rehabilitation Unit

• Men or women

• Able to take part in an out-patient rehabilitation programme

• Clinically stable

• Sedentary

• Provided informed consent to participate in the study

Exclusion Criteria:

• Ward of court

• Walking disorders related to orthopaedic or neuromuscular disease

• Participation in a structured physical reconditioning programme in the month before the study

• Renal insufficiency requiring dialysis

• Known and documented myopathy

• Progressive cancer

• Associated progressive disease causing a deterioration in general health

• Participation in another research protocol

• Skin disorder making it impossible to use TENS

• Absolute contra-indication to physical activity

• Presence of pacemaker / defibrillator

• Pregnant women in the 1st trimester / 12 weeks

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS) is the use of electric current produced by a device to stimulate the nerves that only induces sensory stimulation (without muscle contraction) and is classically used in the treatment of pain.
• SHAM Transcutaneous electrical nerve stimulation (TENS)
Transcutaneous electrical nerve stimulation (TENS) is the use of electric current produced by a device to stimulate the nerves that only induces sensory stimulation (without muscle contraction) and is classically used in the treatment of pain.

Locations

Country	Name	City	State
France	University Hospital of Dijon	Dijon
France	University Hospital of Nîmes	Nîmes
France	Clinique de Saint-Orens	Saint-Orens de Gameville
France	Toulouse University Hospital (CHU de Toulouse)	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking distance without pain (in meters)	the evolution of the claudication distance between the start and the end of the study (1 session of TENS each day , 15 days in total) in the two intervention group (TENS vs SHAM). Measure of change between inclusion and end of study.	Change between J0 and J25 (15 days)
Secondary	maximal oxygen consumption (VO2peak in ml.min)	maximal oxygen consumption (VO2peak in ml.min) Measure of change between inclusion and end of study.	Change between J0 and J25 (15 days)